Slightly more than a year after the Regulation 2017/745 (MDR) came into force, many medical device manufacturers are still struggling with the certification of their products in accordance with the new MDR, which is mandatory in order to place medical devices on the European market. This also applies to legacy devices whose validity period for placing on the market cannot extend beyond the expiration date of the previous certificate and in any case no later than 26/05/2024. Therefore, the issue of certification needs to be urgently addressed.
The MDR involves the addition of specific new requirements. In most cases, significant changes will have to be made to the compliance process, quality management system and technical documentation in order to achieve regulatory compliance.
RPN can support you for all of CE mark certification activities from development to CE mark:
- Strategic support for MD development, classification and clinical assessment
- Contacts with Notified Bodies
- Drafting of Technical Files, including Risk Analysis Report, Clinical Evaluation Report (CER), Biological Evaluation Plan and Report (BEP and BER)
- Quality Management System set-up according to ISO 13485
- CE mark Maintenance Activities (Technical File variations, Support for maintenance audit)
- Specific services to fulfil the Person Responsible for Regulatory Compliance (PRRC) obligation
- Support for promotional material review and submission in Italy
- Support for management of Italian MD Database and EUDAMED (European Database on Medical Devices)
- Support for Clinical Investigation Application submission to Italian ECs and MoH
Don’t get caught unprepared and contact us for your customized gap analysis; you will save time, money and you will be able to better plan the future of your devices.
Regulatory Pharma Net offers full regulatory support and is available for any clarification and assistance, please do not hesitate to contact us at info@regulatorypharmanet.com